In March 2012, the Food and Drug Administration held a pubic hearing in which Janet Woodcock, MD, Director of the FDA’s Center for Drug Evaluation and Research, posed the following questions: Should there be more flexibility in FDA’s concept of non-prescription drugs? Can FDA broaden the assistance that a consumer gets, for example, by augmenting a drug facts box with new technology resources or by using pharmacists to help the consumer understand the condition or treatment better, thereby increasing the types of medications that could potentially be available over the counter?

Where the paradigm addressed asthma and anaphylaxis, FDA suggested that “rescue” medications could be available for emergency situations. This terminology and notion left AANMA shocked and perplexed. Was FDA suggesting there were asthma and anaphylaxis medications that could be used instead of calling 911? Are pharmacies soon to take the place of emergency departments? Would we soon see self-diagnostic testing for all the different possible causes of asthma? Was this a cruel trick to dump healthcare costs for prescription medications out of Medicaid and Medicare?

Allergy & Asthma Network Mothers of Asthmatics and other organizations spoke out against the proposal. However, our voices were drowned out by pharmacy and consumer product associations – that is until Dr. Woodcock invited AANMA President Nancy Sander and Sandra Fusco-Walker, Director of Patient Advocacy, to meet with her and 15 FDA staff members at FDA headquarters in Maryland. Also present by phone were AANMA board member Martha White, MD, and Bobby Lanier, MD, representing the American College of Allergy, Asthma and Immunology.

Here is a small sample of our conversation:

Nancy Sander: Where did the proposal come from? Who and what is behind it?

Janet Woodcock, MD: Let me start by taking full responsibility for it. FDA needs more flexibility in its tools to make it easier for patients to have access to certain drugs under certain conditions of safe use.

Sander: Most people think the paradigm is an attempt to shift federal healthcare costs for the most expensive chronic illness directly to consumers. Rather than co-pays for medications and non-urgent medical care, we’ll pay out-of-pocket for medications recommended by kiosks, computers and pharmacists. How can this be considered safe use?

Dr. Woodcock: That is not what FDA wants to do. We need a better framework than the ancient one we have that says a drug is either sold over-the-counter or with a prescription.

Sander: The way the notice is written, the general public and many medical associations came to different conclusions. Do you have examples that would help us better understand what you are getting at?

Dr. Woodcock: Look at the success of the flu vaccine program in pharmacies. Everyone thought the relationship between a patient and their doctor would be affected, but millions of patients have been successfully vaccinated.

And then you have non-sedating antihistamines. When we had a public hearing a decade ago, AANMA was there. You testified there would be problems if non-sedating antihistamines were sold OTC. Many people agreed with you, but it has been 10 years and there’s been no problem. FDA is looking for better ways to do the same thing.

Sander: The first example was a public health issue whereby the U.S. averted a pandemic. The second example was not a public health issue. A health insurance company – not patients – appealed to FDA to make non-sedating antihistamines OTC.

But are we better off today? My answer would be no. Consumer access does not equal understanding of how or when to use the medications. Did OTC antihistamine access improve school and work performance and absenteeism among patients with seasonal or chronic allergies? No one is counting.

Many families are confused as to which OTC antihistamine to buy out of the many on the store shelves.

Dr. Woodcock: This is something you may hear and see because you are a patient advocate. In all cases of Rx and OTC switches, the FDA looks at a number of different factors including the safety and effectiveness of the product, whether consumer studies support a patient’s ability to self-medicate, and whether the labeling for the product is written in such a manner as to instruct the patient to use the drug properly. In cases of both prescription and OTC medications, patients may not use their medications appropriately. This, as you know, can and does lead to problems.

Sander: The average person does not know how to differentiate between seasonal and chronic allergies, a lingering cold or sinusitis. How long to tolerate symptoms before self-treating or calling a nurse for advice … most don’t know to start using non-sedating antihistamines before the allergy season starts. By the time they head in misery to the store allergy aisle, what they really need are prescription topical nasal sprays and eye drops, inhalers and creams and instructions for using them.

Dr. Woodcock: FDA has the authority to select drugs on a one-by-one basis to determine whether a drug should be OTC or Rx. But what we are seeking here is a tool so that if a patient is in a special situation to self-select a drug through a condition of safe use, they can get their medication without having to get a prescription. With electronic prescribing, healthcare providers including pharmacists are in a good position to know all the different types of medications a patient may be on and if the patient needs to obtain additional medical care.

Sander: We don’t see how this applies to asthma and anaphylaxis. We have to get past the idea that asthma is a little cough that comes along and treatment is a self-selected puff away or that when it happens, you just run to the pharmacy, buy an inhaler and life is good. Eleven people die of asthma every day. Patients need a comprehensive diagnosis to know how to treat and prevent the causes of symptoms. They deserve physician and specialist-directed care and should be taught that asthma is serious and to keep bronchodilators closer than their cell phones.

And for epinephrine auto-injector refills, nothing could be easier. After using the device, you are supposed to report to a hospital where upon discharge you are given a refill for two devices that can be filled at any pharmacy.

I think one of the biggest problems with FDA’s paradigm is it characterizes albuterol and bronchodilators in general as a “rescue” therapy as if it was a life jacket. Look at the package insert. It clearly states that albuterol should be used at the first sign of symptoms and before exercise. It will not re-inflate or reopen fluid-filled and mucous-plugged airways. It never claims it will rescue a patient although this misleading slang terminology has made it into advertising.

People should understand that when you die of asthma, you are drowning in mucous and fluid. It is no more possible to re-inflate clogged airways than it is to blow up a glue-filled balloon. The same is true of epinephrine auto-injectors for anaphylaxis.

Dr. Woodcock: It is our intention for patients to use their products as directed by their healthcare professional and as described in the product’s labeling. This is why we are seeking input on the use of new technologies that may facilitate patients’ ability to self-select their medications, allowing for greater access to those drugs.

Sander: The NHLBI Guidelines for the Diagnosis and Management of Asthma no longer use such terminology. We respectfully request that FDA also discontinue the use of the term “rescue” as a synonym for any bronchodilator and remove the term from FDA documents and patient information.

Dr. Woodcock: That is a discussion that can be explored with the Division of Pulmonary, Allergy and Rheumatology Products.

Sander: Thank you. So we are clear, FDA does not intend for pharmacists or kiosks to rescue patients in peril by selling them inhalers or epinephrine auto-injectors in pharmacies during asthma and anaphylaxis attacks?

Dr. Woodcock: Patients experiencing an asthma attack or anaphylaxis should seek emergency medical attention. FDA agrees that all healthcare professionals, including physicians, play a vital role in the healthcare system and in no way seeks to undermine that role.

Sander: I think we’ve made the case to eliminate asthma and anaphylaxis from FDA’s proposed paradigm.

Dr. Woodcock: Well, we’re also considering how to help patients who don’t have access to health care and need drugs for other chronic conditions or diseases, not just allergy and asthma. FDA recognizes that the availability of OTC drugs has empowered consumers with self-care options to better treat and manage conditions and diseases that can be self-diagnosed and self-treated. FDA believes it is worthwhile to explore whether there are tools that could be used to safely expand the scope of drugs that are available for OTC use and how expanding the scope could lead to improved public health.

Sander: OTC access to medication does not necessarily mean patients are going to be well. OTC access does not necessarily mean medications will be more affordable. For example, private and public charitable foundations provide free Rx medication, medical care and co-pays to patients in need. In FDA’s Rx-to-OTC paradigm, those benefits evaporate.

How does the paradigm protect poor and middle class families with health insurance who lose prescription and doctor visit co-pays when the paradigm becomes reality? As it is, IRS requires a prescription for our OTC purchases if we want to be reimbursed through our Health Savings Accounts and our Federal Savings Accounts.

Dr. Woodcock: These are important points you raise. All of us are here today because it is important to listen to patients’ concerns.

Sander: Patients are under-represented in this discussion. We already have the tools necessary to improve healthcare outcomes while reducing cost in allergy and asthma.

Dr. Woodcock: This change will not happen overnight. We will continue to work with the public and we encourage feedback on this paradigm from patients and consumers. Let’s continue to work together.